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TuberculosisRECONNCT02234908

Rewards for Tuberculosis Contact Screening

A study testing Contacts and Index in people with Tuberculosis and Drug-resistant Tuberculosis, run by Boston University at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV… Read more about this study

Who is it for?
Any age
Conditions the study is for
Tuberculosis, Drug-resistant Tuberculosis
What is being tested?
Contacts and Index
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
2 sitesSouth Africa
Study dates
Oct 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adult patients (>18 years)
  • Newly diagnosed with pulmonary TB (drug-susceptible or drug-resistant) or initiating treatment for TB at one of the study sites
  • Usually spend at least 4 nights per week in the same household as an index case
  • Can provide referral card given to contact by index patient
  • Experience with the intervention as provider or patient
  • Written informed consent to be interviewed

Who cannot join

  • Resident outside the site's permissible catchment area for service delivery
  • No household contacts (live alone)
  • Admitted for inpatient care immediately following their TB diagnosis, and thus not readily able to distribute the referral cards
  • Not physically, mentally, or emotionally able to participate in the study, in the view of study staff
  • Previously enrolled in the same study
  • Declines to provide written informed consent to participate
Show all 13Show fewer
  • Unable to speak any of the languages for which consent documents are available and not accompanied by person who can
  • Currently on any type of TB treatment
  • Not able to present any form of identification that matches the information on the referral card
  • Previously enrolled in the same study
  • Declines to provide written informed consent to participate
  • Unable to speak any of the languages for which consent documents are available and not accompanied by person who can
  • None

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites
  • Helen Joseph Hospital

    Johannesburg, 2193

  • OR Tambo Clinic

    Johannesburg

Other trials in South Africa

About this study

This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV testing, providing a reward to the index patients for participating, and entering index patients whose contacts do present into a lottery to win a prize.The effectiveness of the intervention in screening a high proportion of contacts will be compared to existing published data from studies of active case-finding through home visits and of the status quo passive case finding. If successful, this pilot project will create a demand for screening among high risk patients, who will be rewarded for identifying themselves to the healthcare system, and could prove to be an affordable alternative to resource-intensive home visits. It will also shift responsibility for contact tracing from overburdened clinic staff to those who have the most to gain from early case detection-the patients and their families.

Read the detailed description

Despite the success of antiretroviral treatment (ART) programs in reaching > 10 million HIV-infected patients in resource-limited countries over the past decade, HIV and tuberculosis (TB), continue to take a heavy toll on survival and health in southern Africa. In South Africa, where 6.4 million people are estimated to be HIV-positive and up to 2.1 million are on ART, TB incidence is the second highest in the world (after Swaziland), 65% of TB patients are HIV-infected, and TB remains the leading natural cause of death. Drug-resistant TB (DR-TB) is even more concerning, with more than 15,000 South African patients diagnosed with multidrug-resistant TB (MDR-TB) in 2012, nearly a fifth of the global total, and very high mortality among those receiving standard MDR-TB treatment.

Because of the high risk of both TB and HIV among the household contacts of TB patients and the importance of early case detection for both diseases and especially for DR-TB, improving TB case finding is a high priority. Recent studies have shown that having healthcare workers make multiple visits to the homes of TB patients in order to screen household contacts is a logistically challenging and resource- intensive strategy, and it is not routinely undertaken in most public sector settings in South Africa. One alternative to home visits that could prove effective and affordable is to offer small economic rewards to the household contacts of TB patients who voluntarily present at a healthcare facility for TB symptom screening and optional HIV testing. Economic incentives have been successful in increasing demand for healthcare in a variety of settings, but they have not been tried before as a way to increase uptake of services among patients' contacts, rather than among the diagnosed patients themselves.

This pilot project is an evaluation of the feasibility and results of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV testing, providing a reward to the index patients for participating, and entering index patients whose contacts do present into a lottery to win a prize. The effectiveness of the intervention in screening a high proportion of contacts will be compared to existing published data from studies of active case-finding through home visits and of the status quo passive case finding. If successful, this pilot project will create a demand for screening among high risk patients, who will be rewarded for identifying themselves to the healthcare system, and could prove to be an affordable alternative to resource-intensive home visits. It will also shift responsibility for contact tracing from overburdened clinic staff to those who have the most to gain from early case detection-the patients and their families.

Being tested
Contacts, Index
Keywords
Tuberculosis, Drug-resistant tuberculosis, Incentives, Symptom screening
Medical subject headings
Tuberculosis, Tuberculosis, Multidrug-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ContactsBehavioural

    Household contacts who come to the study clinic, present a referral card, and complete TB symptom screening will receive a shopping voucher of $5-10 value.

  • IndexBehavioural

    Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.

Study groups in NCT02234908
Study groupRoleWhat they receive
ContactsExperimentalContacts are the household contacts of confirmed TB and drug-resistant TB patients.
Receives: Behavioral: Contacts
IndexOtherIndex subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.
Receives: Behavioral: Index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of household contacts volunteering for TB symptom screening

    The primary quantitative outcome is uptake of TB symptom screening, defined as the proportion of reported household contacts who complete TB symptom screening within 1 month of index subject enrollment.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJan 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02234908
Sponsor's protocol ID
H-33047
Other IDs
M140529, 1U01AI100015-01
Acronym
RECON
Status last verified
Jan 2021
First submitted
5 Sep 2014
Last updated
8 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Contacts and Index in people with Tuberculosis and Drug-resistant Tuberculosis, run by Boston University at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of household contacts volunteering for TB symptom screening (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.

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Rewards for Tuberculosis Contact Screening | AzTrials